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© 2020 MJH Life Sciences and BioPharm International. All rights reserved.
© 2020 MJH Life Sciences™ and BioPharm International. All rights reserved.
October 22, 2020
The agency’s Vaccines and Related Biological Products Advisory Committee met to discuss COVID-19 vaccine approvals, post-marketing safety studies, and ongoing safety monitoring of vaccines.
October 19, 2020
The much-anticipated meeting of FDA’s vaccine advisory committee this week is slated to address a number of critical issues related to testing and approval of vaccines to prevent COVID-19 infection.
October 13, 2020
Virtual Touring allows companies to inspect and visit vendor and contract partner sites remotely during the COVID-19 pandemic.
The unexplained illness in a study participant is being reviewed and evaluated by an independent data safety monitoring board and internal clinical and safety physicians.
The company will supply its LIMS to the Walter Reed Army Institute of Research (WRAIR) to support vaccine production programs for COVID-19 at WRAIR’s pilot bioproduction facility.
October 12, 2020
The companies are entering into an agreement for the late-stage development and large-scale manufacturing of AZD7442, AstraZeneca’s investigational product for treatment and prevention of COVID-19.
October 09, 2020
Rentschler will handle the downstream processing to provide highly purified drug substance at its headquarters in Laupheim, Germany.
October 08, 2020
Independent research performed at the University of St. Andrews in the UK has reportedly demonstrated the effectiveness of Alfacyte in-vitro against SARS-CoV-2.
October 07, 2020
The guidance provides recommendations for data and information needed to support an EUA for COVID-19 vaccines.
October 06, 2020
The study, entitled CV-NCOV-002, is being held in Peru and Panama and has enrolled 690 participants, including older adults ages 61 and above, and younger participants 18 to 60 years old.
Experts fear confusion over allocation process, cold-chain requirements, IT systems.
October 05, 2020
The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicines.
October 02, 2020
The European Medicines Agency has started a rolling review of AstraZeneca’s COVID-19 vaccine.
October 01, 2020
Fill/finish inspection for vaccine vials and syringes must remain GMP-compliant while aiming for fast, efficient methods.
Misleading messages contribute to eroding trust in public health agencies
The Serum Institute of India will receive upfront capital to expand manufacturing capacity, pending vaccine approval, to ensure distribution.
The 60,000-ft2 facility was built using CRB’s ONEsolution project delivery method and was designed to expand GRAM’s large-scale fill/finish capacity.
September 28, 2020
Par Sterile will produce the vaccine for use in Novavax's Phase III clinical trial in the United States, while also providing fill/finish services for commercial distribution in the US.
GRAM is expanding fill/finish capacity and is working with Janssen on tech transfer in preparation for production of Janssen’s SARS-CoV-2 vaccine candidate at GRAM’s Grand Rapids, MI facility.
September 25, 2020
A clinical trial to enroll up to 10,000 volunteers across the UK will assess whether NVX-CoV2373 is effective in the prevention of COVID-19.